Home NDC 42043-161 Modafinil
Product NDC 42043-161
11-digit product format 420430161
Labeler code 42043
Product ID 42043-161_dc738068-3e56-47c5-afd8-7d471303c041
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Modafinil
Dosage form TABLET
Route ORAL
Labeler OrchidPharma Inc
Application ANDA078963
Marketing category ANDA
Marketing start 2013-08-01
Marketing end 0000-00-00
Substance MODAFINIL
Active strength 200 mg/1
Pharmacologic classes Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 60 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 42043-161-90 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 42043-161-03 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 42043-161-01 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 42043-161-90 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 42043-161-03 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 42043-161-01 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 42043-161-90 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 42043-161-03 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 42043-161-01 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 42043-161-90 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 42043-161-03 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 42043-161-01 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 42043-161-90 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 42043-161-03 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 42043-161-01 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 42043-161-90 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 42043-161-03 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 42043-161-01 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 42043-161-90 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 42043-161-03 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 42043-161-01 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 42043-161-90 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 42043-161-03 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 42043-161-01 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 42043-161-90 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 42043-161-03 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 42043-161-01 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 42043-161-03 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 42043-161-01 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 42043-161-90 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 42043-161-03 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 42043-161-01 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 42043-161-90 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 42043-161-03 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 42043-161-01 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 42043-161-90 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 42043-161-03 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 42043-161-01 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 42043-161-90 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 42043-161-03 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 42043-161-01 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 42043-161-90 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 42043-161-03 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 42043-161-01 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 42043-161-90 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078963-001 MODAFINIL MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 A078963-002 MODAFINIL MODAFINIL 200MG TABLET / ORAL AB 2012-09-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 42043-161-01 2024-12-23 These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, C-IV Initial U.S. Approval: 1998 42043-161-03 2024-12-23 These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, C-IV Initial U.S. Approval: 1998 42043-161-90 2024-12-23 These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, C-IV Initial U.S. Approval: 1998 42043-161-01 2023-07-28 These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, C-IV Initial U.S. Approval: 1998 42043-161-03 2023-07-28 These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, C-IV Initial U.S. Approval: 1998 42043-161-90 2023-07-28 These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, C-IV Initial U.S. Approval: 1998
DailyMed Socrata Ingredients# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 42043-161-01 42043016101 1 BOTTLE, PLASTIC in 1 CARTON (42043-161-01) > 100 TABLET in 1 BOTTLE, PLASTIC 2013-08-01 0000-00-00 No No Current 42043-161-03 42043016103 1 BOTTLE, PLASTIC in 1 CARTON (42043-161-03) > 30 TABLET in 1 BOTTLE, PLASTIC 2013-08-01 0000-00-00 No No Current 42043-161-90 42043016190 1 BOTTLE, PLASTIC in 1 CARTON (42043-161-90) > 90 TABLET in 1 BOTTLE, PLASTIC 2013-08-01 0000-00-00 No No Current